MXPA04002493A

MXPA04002493A - Lancing aid comprising a lancet system that is protected against re-use.

Info

Publication number: MXPA04002493A
Application number: MXPA04002493A
Authority: MX
Inventors: Ebert Karl-Peter
Original assignee: Hoffmann La Roche
Priority date: 2003-03-20
Filing date: 2004-03-16
Publication date: 2004-12-02
Also published as: US20040260325A1; JP2004283568A; ES2380667T3; KR20040083009A; US7785338B2; PL2452625T3; CN1531905A; EP2452625A1; BRPI0400350A; EP2452625B1; ATE547047T1; EP1459683B1; PL1459683T3; SG148833A1; KR100669869B1; ES2519591T3; AU2004200976B2; JP3851316B2; EP1459683A1; DE10312357B3

Abstract

The present invention is generally directed towards the field of lancing aids in which disposable lancet systems are used. The lancet system according to the invention has a needle body which surrounds the needle tip in a lancet system in a protective manner and also comprises a protection against re-use of an ejected lancet system.

Description

AUXILIARY PENETRATION DEVICE WITH LANCETA COMPRISING LANCET SYSTEM THAT IS PROTECTED AGAINST REUSE DESCRIPTION OF THE INVENTION The invention concerns a lancet system that can be used in an auxiliary lancet penetration apparatus to draw blood for diagnostic purposes. In a variety of diseases it is necessary to examine human blood with respect to an analyte contained therein. In many cases this requires only the removal of a small amount of blood in the form of a drop of blood, producing a small puncture wound. A particularly important example of that case is diabetes, in which the content of glucose in the blood has to be examined at regular intervals. The blood can be examined, for example, with respect to coagulation parameters, triglycerides, HbAlc or lactate. Lancet devices for drawing blood consisting of a lancet augmentation aid and a custom-made replaceable lancet are usually used to produce the required puncture wounds. The housing of the lancet instrument contains a lancet holder in which an interchangeable lancet can be inserted. During the lancet penetration operation, the slider is moved quickly, in a direction of penetration with RER: 153188 lancet, by a lancet impeller, which is also integrated in the lancet penetration aid, until the tip of the needle exits through an outlet hole provided at the front end of the auxiliary penetration apparatus with lancet, and produces a small puncture wound on the part of the body that is pressed against the front end. Subsequently, the lancet holder holding the lancet moves backwards in the opposite direction of lancet penetration. Currently, small, easy-to-use blood collection devices, called lancet penetration aids, are routinely used, which can be operated easily and reliably by the user and allow part of the body to be penetrated in an almost painless manner. . In order to avoid infections, especially in hospitals, lancets are disposable items that are used only once. After a lancet has been used, the lancet is removed after the penetration operation or is ejected from the device and discarded as garbage. In that case the needles exposed in a trash receptacle can cause injuries during waste disposal, resulting in contamination of other people by the used lancet. Such contamination can lead to infections and therefore some countries are planning to impose bans on blood collection systems in which the needle tip is exposed freely after use. In addition to the risk of injury during waste disposal there is also a risk that a used lancet may be accidentally reused. This is particularly relevant for hospitals, in which an auxiliary penetration device could be used for several patients due to the carelessness of the nursing staff, which would cause a patient to be contaminated with the blood of a previous patient. In addition to the use of lancet devices to draw blood, by medical personnel, lancet penetration aids are also used by people outside the medical field, in the field known as the home monitoring field. This is particularly the case for monitoring the treatment of diabetics. Therefore, it has been discovered in the treatment of diabetics, that the serious damage associated with diabetes, such as the loss of sight, can be substantially reduced when the diabetic blood glucose concentration is frequently determined and up to five times a day and the insulin injection is adjusted exactly based on these measurements. Auxiliary devices for penetration with a lancet, which allow the diabetic to carry out that blood test, are used for monitoring at home in order to make those frequent measurements. The resulting requirements for a lancet device to draw blood consists of simple handling when inserting new lancets and a reliable ejection of used lancets, in addition to simple handling when the lancet penetration operation is performed and a relatively unimportant puncture. pain. The replacement of the lancet should be, on the one hand, as simple as possible, and on the other, it should ensure extreme security with respect to an unintentional injury of the user or other persons. Although in the field of home monitoring it is conceivable that a lancet, once inserted, is used several times by the same user to perform the penetration, even in this case the reuse of an ejected lancet will be prevented, once the user has decided to discard the lancet. In addition, other people in particular should be reliably protected against discarded lancets, for example during waste disposal. In the prior art the tip of the needle is usually surrounded by a tip cover made of plastic, when the lancet is inserted, which allows a safe insertion of the lancet. When the lancet is inserted, the tip cover is removed to expose the sharp point of the needle for the lancet penetration operation (U.S. Patent 5,628,765). However, due to the exposed tip of the needle there is a risk of accidental injury and the tip may be damaged. The lancet is removed from the lancet penetration aid after one or several lancet penetration operations. This can be carried out either manually, in which case there is a high risk of injury with the tip of the needle, or by an automatic ejection mechanism. In EP 0565970 there is described a lancet device for drawing blood, in which the lancet is ejected from the lancet holder by means of an expulsion rod. The user can operate the ejection rod by pressing a corresponding button. Furthermore, in US Pat. No. 4,442,836 an ejection mechanism is described wherein the needle is released automatically when the auxiliary penetration apparatus is retensioned such that the used lancet is discarded before each operation of penetration with lancet. These ejection mechanisms require a relatively large degree of engineering design, additional. Furthermore, the multiple use of a lancet system already inserted is not possible but, nevertheless, it is often desired by customers, especially in the home monitoring field. Another major disadvantage of the prior art described is that the tip of the needle is not protected after the lancet has been expelled, resulting in the risk of injury described above.

In order to facilitate the safe removal of a used lancet, prior art also describes blood collection systems which ensure that the needle tip is protected after ejecting the lancet. This is considered an important characteristic, especially for elderly users or those disabled due to poor eyesight and trembling hands, as a result of illness. In the prior art, protection of the tip of the needle is achieved by integrating the lancet into a cover of the lancet penetration aid, such that the lancet and the cover of the housing together form a replaceable disposable unit. These designs are described in EP 0595148, US 4,990,154, US 5,454,828 and DE 10053974. When the lancet is expelled by the user, the cover of the housing is placed on top of the needle tip, such that the lancet surrounded by the lid can be discarded subsequently. Even if the tip of the needle is protected after ejection due to the mechanism described, it is possible, nevertheless, that a careless user re-insert a needle that has been ejected and carry out a new lancet penetration operation. . Consequently, instructions are given to the user to recognize that the needle has already been used.

Only document EP 0630609 describes a mechanism that directly prevents reinsertion and therefore the reuse of a lancet that has already been ejected once. The disclosed lancet device comprises a needle with a needle body that breaks when the needle is ejected from the lancet-assisting apparatus to prevent reinsertion of the needle. This prevents the user from using a contaminated needle again. However, a disadvantage of the prior art is that the tip of the needle is left unprotected after the needle has been expelled. The object of the invention is to provide an easy-to-use lancet penetration aid for the home monitoring field, which prevents the reuse of an already ejected lancet system and also ensures protection against injuries caused by the tip. of a needle, after the lancet system has been ejected. It would be possible, advantageously, to easily reuse a needle from a lancet system that has been inserted once. The object is achieved by an auxiliary lancet penetration apparatus, and with a lancet system in accordance with the independent claims. Preferred embodiments are derived from the dependent claims.

The invention concerns a lancet system and an auxiliary lancet penetration apparatus, which contains the lancet system. The lancet penetration aid has a housing for inserting a lancet system. The housing also has a hole through which the tip of the needle can exit from the housing and a drive to perform a lancet penetration operation. According to the invention, the housing additionally has a fastening element that can interact with a corresponding fastening element of the lancet system, as soon as the lancet system has been inserted into the lancet penetration aid. The interaction between the clamping elements allows the lancet system to be placed in the housing at a defined site. An accurate positioning of the lancet system is important especially with respect to the drive mechanism for the lancet penetration aid, since it is the only way in which the needle can be properly coupled to the drive mechanism, so that the needle can Perform a penetration operation at fast speed and almost without vibration. This allows a quick and relatively painless puncture in the desired part of the body. In addition to the described fastening element, the lancet system for the lancet penetration aid comprises at least one needle with a tip which is suitable for producing a hole in the skin. The needle is connected to a needle body and at least one protective portion of the body of the needle and needle can be removed relative to each other. In a first position the tip of the needle is surrounded, at least partially, by the protective portion of the needle body, while in a second position the protective portion of the needle body, and the tip of the needle, is they are positioned, one relative to the other, in such a way that the tip of the needle is released from the protective portion of the needle body. If the protective portion of the needle body is in its first position, and therefore protects against any injury caused by the tip of the lancet which is particularly important after the lancet system has been ejected from the auxiliary penetration device with lancet. The body of the needle also contains a locking mechanism that is activated by an iteration with the lancet penetration aid. The locking mechanism changes the body of the needle in such a way that after the lancet system has been ejected from the auxiliary penetration apparatus, the fastening element on the auxiliary penetration apparatus can no longer interact with the insert element. holding the lancet penetration aid when it is reinserted. This prevents the reuse of a lancet system that has been ejected once. In this connection, the locking mechanism can be activated automatically as soon as certain operating steps have been carried out in the auxiliary penetration device. However, other embodiments are conceived in which the user operates the locking mechanism by means of a separate operation step. As a result of the special design of the needle body, the lancet system according to the invention provides protection against the tip of the needle, such that after ejection of the lancet system, the tip is surrounded by the lancet. protective portion of the needle body, to a degree such that an injury caused by the tip is prevented. The locking mechanism also influences the interaction of the fastening elements. Within the scope of the invention the term "interaction of the fasteners" encompasses any conceivable embodiment known in the prior art for inserting and placing a lancet or a cartridge in an auxiliary lancet penetration apparatus. For example, the fastening elements can be pressed or clamped. Suitable fastening elements for this may be designed, for example, as lugs, slots or hooks to name only a few possible modes. Similar to the systems described in the prior art which contain individual lancets, it is also conceivable that the lancet system is already properly placed and retained in the lancet penetration aid, due to its coupling with the drive unit, Such that, for example, the driving unit itself can be used as fastening elements for a properly designed lancet system. If several fastening elements are provided for positioning the lancet system, the locking mechanism advantageously prevents an interaction between the fastening elements of the lancet system and the lancet penetration aid, such that the lancet system can not be maintained and placed in the lancet penetration aid. This is particularly advantageous when the lancet system and the lancet-assisting auxiliary apparatus each have several fastening elements that act independently of one another. In a preferred embodiment, the interaction of the fastening elements is blocked in such a way that the lancet system is prevented from being reinserted into the lancet penetration aid. Within the scope of the invention the term "reinsertion" encompasses a manipulation of the lancet system, in such a way that the lancet system is placed in the position in the lancet penetration aid, which serves to carry out the lancet penetration operation and sustained therein due to the interaction of the fastening elements. For this purpose, the lancet system is used again in its original position in the lancet penetration aid, thus restoring the original state of the lancet system and the auxiliary penetration device that was present when the device was first used. penetration aid with lancet. When the lancet penetration aid is operated, the user can, advantageously, immediately and unambiguously, identify an already used lancet system, for example, due to the fact that reinserting the lancet cartridge into the auxiliary apparatus of penetration with lancet, is blocked. Hence, in contrast to the prior art, the user is not required to consciously distinguish between a used lancet system and a new lancet system. Advantageously, the user is prevented from unnecessarily re-inserting a used lancet system that no longer functions and that elderly and visually impaired people often find difficult. However, it is also possible for the locking mechanism to block only the lancet penetration operation, in which case it is possible to reinsert a needle that has already been ejected. If the insertion of a lancet system is prevented, this usually means that the lancet system can not be attached to the drive unit. In a preferred embodiment, the locking mechanism is essentially achieved by a change in the shape of the needle body. This proves to be particuy advantageous when the shape of the needle body forms itself at least a part of a fastening element. It is also possible that the deformation of the needle body spatially separates the fastening elements in the lancet penetration aid, in such a way that the locking mechanism has an indirect effect on a fastening element, without directly acting on it. . Hence, the lancet system can no longer be placed and held in a defined position in the lancet-assisting apparatus. In a preferred embodiment, the deformation of the needle body transfers the protective portion of the needle body to a first position, such that there is no risk of injury when a used lancet is placed. The protective portion of the needle body and the locking mechanism are then achieved as a single component of the lancet system. In principle, fasteners can interact in a variety of ways. The locking mechanism can have a direct or indirect effect on the fastening elements. In the case of a direct effect on the fastening elements, at least one fastening element is changed, covered or destroyed, advantageously, in such a way that the interaction of the fastening elements is no longer possible. Further embodiments are also conceivable, in which the lancet system is placed within an auxiliary lancet penetration apparatus, due to the magnetic properties of the system. Hence, a change in the magnetic properties of the needle body could prevent the reuse of the lancet system. Appropriate magnetic elements of the body of the needle or of the auxiliary apparatus for penetration with lancet, are then the fasteners of the system. Since the locking mechanism only advantageously prevents a repeated insertion of the lancet system, but does not prevent the reuse of a needle that has already been inserted, the lancet system also satisfies requirements in the home monitoring field, where the multiple use of a previously inserted needle is often desired. The lancet penetration aid according to the invention, to collect blood, has a drive unit with a piston that moves a needle from its resting position to a penetration position. A number of driving mechanisms are known in the prior art and can be used in the field of devices for blood collection (for example US 5,314,442, WO 00/02482, US 3,030,959). In particular, drive mechanisms that derive their energy from a previously tensioned spring are frequently used. Within the scope of the present invention, preference is given to using driving units which allow a guided movement of the piston and needle, for example as a result of an adjustment coupling to the shape, as described in DE 10053974. The guided movements of the needle, for example by guide blocks, have also been previously described in EP 0565970. Those driving mechanisms are preferred because the puncture is less painful. However, the system according to the invention is not limited to a particular driving mechanism, but on the contrary can be combined with a variety of driving units. An important aspect of the invention is a lancet system that can be disengaged from the drive unit containing at least one needle, wherein the lancet system is provided as a disposable unit. In this regard, the term "needle" encompasses a lancet penetrating unit, substantially flat, blade-shaped, and all other conceivable embodiments thereof. In principle, needles can be used for the invention, which are basically well known in the prior art, and which can be used in a lancet system. In the prior art a needle is often combined with a base body that can be coupled to the lancet-assisting apparatus, which is referred to as a lancet. These lancets often have a base body made of plastic, in which a metal needle is placed. In accordance with the invention it is possible to integrate that lancet into the lancet system according to the invention. For example it is conceivable that the body of the needle according to the invention contains a base body such as that used for lancets in the prior art, wherein the inventive functionality of the system is maintained by the integration of the base body. In this case the body of the needle has a design of at least two parts according to the described modality. In a preferred embodiment, the needle body is designed in such a way that a plurality of lancets are placed in the body of the needle, such that the body of the needle represents a cartridge containing a plurality of lancets and each The base body of the lancet represents a part of the body of the needle. Accordingly, in a preferred embodiment, the protective portion of the needle body is formed by the housing of the cartridge. The needle and the base body can then be guided in a mobile manner within the cartridge. The needles within the body of a needle designed according to the invention as a cartridge, are preferably present in separate chambers, in order to prevent contamination of unused needles, by needles used when recharging is performed. In order to carry out the lancet penetration operation, portions of the needle body are advantageously designed like the system already described in DE 10053974 in such a way that individual needles of the system can be actively coupled to the drive unit of the apparatus. penetration aid with lancet. Modalities that can also be used to propel needles into a cartridge of a lancet penetration aid are described, for example, in DE 10053974, US 4,990,154 and US 5,074,872. The chambers arranged next to each other, in which the lancets are located individually, they are placed successively in relation to the driving unit, in order to carry out the lancet penetration operation, in such a way that in each case an individual needle can be coupled to the plunger of the driving unit. Also, in this case, cartridges in the shape of a drum containing chambers in which the needles are located parallel to the longitudinal axis of the drum have also proven to be particularly advantageous.

The lancet system also comprises a needle body which at least partially surrounds the tip of the needle by means of the protective portion of the body, when the needle is in its rest position. In order to carry out the lancet penetration operation, the protective portion of the needle body is spatially separated from the tip of the needle, such that the protective portion of the needle body does not impede the penetration operation. with lancet. When the lancet system is ejected from the lancing aid, the needle remains in its rest position, so that the tip of the ejected needle is protected and additionally the locking mechanism according to the invention prevents reuse of the lancet system. However, it is also possible that the protective portion of the needle body is not transferred to its first position, until the lancet system is ejected, so that the tip of the needle is protected only as a result of ejection. In a preferred embodiment, an unused needle is also in a rest position before insertion into the lancet penetration aid to prevent injuries caused by the needle tip and contamination when the needle is inserted as well as after the needle. expulsion.

A locking mechanism according to the invention can be actuated, for example, when the lancet system is ejected from the lancet insertion aid, or inserted therein, independently of the protection against the tip of the needle. In principle, the locking mechanism or the protections of the needle tip can be activated separately or by individual operation steps of the lancet penetration aid, for example during the lancet penetration operation. In general, all the possible combinations that ensure a locking and protection mechanism of the needle tip, simultaneous or successive, are conceivable. The locking mechanism can have a variety of designs but it is advantageous that the shape of the needle body be changed in such a way that it is no longer possible to reinsert a lancet system once it has been ejected. For example, the locking mechanism can move at least a part of the body of the needle that interacts with the lancet-assisting apparatus, in such a way that a change in its position blocks the reinsertion of the lancet system. This is for example the case when the locking mechanism closes a notch in the body of the needle that forms a fastening element, or a notch is generated in the body of the needle that is essential for an interaction of the lancet system with a penetration aid with lancet. In addition, it is also possible for the locking mechanism to comprise a predetermined breaking point that results in the breakage of the needle body when the lancet system is ejected. It is also conceived that the body of the needle be enlarged, made smaller or bent, which are only a few methods to deform the body of the needle. According to the invention, an interaction between the lancet system and the lancet penetration aid activates the locking mechanism and fixes a first position of the protective portion where the protective portion at least partially surrounds the tip of the needle. An important requirement for the lancet system is that the tip of the needle that is used to produce a wound in an appropriate part of the body, is sterile. The sterility of the tip of the needle has to be ensured for a long period that extends from the manufacture of the lancet system to its use. Sterility can be achieved during the manufacture of the lancet system, for example by gamma radiation which is commonly used in the prior art. In order to maintain sterility, the lancet system can be sealed in a wrapper, for example a polyethylene bag. In another embodiment, the opening of the lancet system, where the needle tip of the protective portion of the needle body emerges, can be closed, for example, by a thin metal foil sealer. These are preferably thin, detachable metal sealing papers, which the user removes before using the lancet system. However, it is also possible to use thin metallic papers that are not punctured by the tip of the needle until the needle is used, so that the user does not have to carry out additional handling steps. Those thin metallic papers can already be used as an integral part of the manufacturing process for the lancet system, which is usually carried out through an injection molding process. Furthermore, in the prior art, an elastomer is described in the application WO 01/66010 for sterile protection, which encloses the tip of the needle and therefore protects it against contamination. This sterile protection can be either perforated during the lancet penetration operation, or it can be removed by the operator before use. In another advantageous embodiment the protective portion of the needle body may comprise a sterile shield and / or the shield portion may be formed essentially thereof. In this case the elastomer of the sterile protection serves, for example, as the protective portion of the needle body, in that the tip of the needle can be moved in a guided manner relative to the elastomer. Another part of the body of the needle that can be operated independently of the sterile protection, can change the body of the needle and represents the locking mechanism. This requires that the sterile protection can reversibly expose the tip of the needle and surround it again, which is for example the case with an elastomeric protection (WO 01/66010) in which the elastomer is drilled first during the penetration operation. with lancet and subsequently the tip of the needle is retracted into the elastomer. Consequently in this example the tip of the needle changes its position relative to the sterile protection, during the lancet penetration operation, and the tip of the needle is protected by the sterile protection in its rest position, after the operation of penetration with lancet. In principle many modalities of sterile protection are conceivable and hence the inventive system is not limited to any special form of sterile protection. The system according to the invention is illustrated in the following, based on the figures and examples, without being limited to the individual examples. BRIEF DESCRIPTION OF THE DRAWINGS Figures la-Id: Two-part lancet system Figures 2a-2d: Lancet system in which the locking mechanism is activated during lancet penetration operation. Figures 3a-3f: Lancet system with a locking mechanism that is activated when the system is ejected. Figures 4a-4d: Lancing system with a locking mechanism that prevents an auxiliary lancet penetrating device from engaging the lancet system. Figures 5a-5c: Lancet system with a locking mechanism that is activated when inserted into the lancet penetration aid. Figures 6a-6h: Auxiliary penetration device with lancet, with a lancet cartridge. La-Te Figures: Lancing system with a locking mechanism that widens the body of the needle. DETAILED DESCRIPTION OF THE FIGURES Figure 1 shows a lancet system (1) consisting essentially of two parts. Figures Ib and Id each show a cross-section through the lancet system shown in the figure and before and after use, respectively. The system has a needle (3), the front tip of which is wrapped in a sterile manner in an elastomeric protection (4). Those elastomers that ensure the sterility of the tip of a needle are known, for example, from WO 01/66010 to which reference is made herein. The metal needle (3) is attached to a plastic body (2b) and is permanently connected to it. The plastic body has a back portion (6) that couples the lancet system to an actuator symbol, such that the needle can move along the axis (8) in the direction of lancet penetration. The back portion (6) of the plastic body, which is a part of the body of the needle, comprises two arms that can be connected in a manner to fit the shape, during the lancet penetration operation, with an actuator piston of an apparatus penetration aid 'with lancet (not shown) by the projecting parts (11). A connection for adjustment to the shape, between an actuator plunger and a lancet, is described, for example, in DE 10053974 which is also referred to herein. Of course, any other coupling mechanism that is described in the prior art is conceivable to carry out the lancet penetration operation. The needle (3) and the plastic body (2b) which is permanently connected to it, are movably mounted on the plastic body (2a) which represents the protective portion of the needle body. The needle and the second part of the body (2b) of the needle can be moved within this body of the needle, along the direction of lancet penetration. The protective portion of the body (2a) of the needle has a lower wall (10) having a hole (9) through which the tip of the needle can exit during the lancet penetration operation. The body of the needle also has a hole (7) at its upper end, through which an actuator piston of an auxiliary lancet penetration device can be inserted, inside the body of the needle, in order to connect, in a way of adjustment by the shape, with the second part of the body of the needle and carry out the penetration operation with lancet. The protective portion of the body (2a) of the needle also has two notches (13 and 14) that allow it to be secured in the second part of the body (2b) of the needle. In order to allow the second part of the body of the needle to engage in the protective portion, the rear portion (6) of the second part of the body of the needle also has closing lugs (12) which engage in the notches. (14) in a first resting position, of the lancet system, before use, and hold the second part of the needle body due to the open arms (6). The middle portion of the protective portion and of the second part of the needle body has a bucket-shaped taper (5 and 5 ') of the body, such that the tapered portions (5 and 5') fit exactly one with the other, in the first rest state, before the lancet system is used and the lancet system in this position has the design shown in figure la.

In order to carry out the lancet penetration operation, a plunger (not shown) of the lancet penetration aid is engaged, through the hole (7) in the lancet system where the plunger is connected, in a way of adjusting for the shape, with the arms (6) of the second part of the body of the needle. As a result the arms (6) are pressed together, so that the lugs (12) of the arms (6) do not fit anymore into the notches (14) and the needle can move forward and along the the direction of penetration with lancet (8) in this process the elastomeric protection (4) is first pressed against the lower wall (10) of the body (2a) of the needle. If the lancet penetration operation is continued, the needle is propelled through the elastomeric protection and can therefore exit the hole (9) in the lower wall (10) and produce a wound in the desired part of the wound. body. The elastomeric protection (4) is meanwhile held backward by the wall (10) as a result of which the front part (15) of the second part of the body (2b) of the needle corresponding to the notch (16) it can move through the elastomeric protection. After the lancet-penetrating operation has been carried out, the body (2b) of the needle and the needle subsequently retract towards the protective portion (2a) due to the shape-fitting coupling to the driving plunger. Once the rear arms (6) are in the rear protective portion of the body (2a) of the needle, the lugs (12) can be engaged in the groove (13) of the body (2a) of the needle when the body ( 2b) of the needle is pulled back. The lancet system is now in a second rest position after the lancet penetration operation. In this position the second part of the body (2b) of the needle protrudes from the hole (5) of the protective portion of the body (2a) of the needle in such a way that the body of the needle is deformed in this area. The tapered portions (5 and 5 ') no longer fit together. In a lancet assisting apparatus, designed in a corresponding manner, which only allows insertion into a lancet system when the tapered part (5) of the needle body is completely formed according to the figure, the insertion of an already used lancet system is blocked according to figure 1c. The example shown in Figure 1 has a locking mechanism and allows the protective portion of the needle body to be transferred to a first position during the lancet penetration operation. When the lancet system is ejected after the needles have been used, the shape of the system has already been changed in such a way that it is no longer possible to reinsert the lancet system into an appropriately designed lancet assist apparatus. In addition, the tip of the needle is completely surrounded by the protective portion and hence there is no risk of injury to other persons, for example during waste disposal. Figure 2 shows a lancet system in the form of a lancet cartridge, essentially round. In comparison with FIG. 1, the protective portion of the body (2a) of the needle is designed solely as a cartridge, in such a way that a plurality of needles (3) can be movably guided therein. Figure 2a shows an exterior view of a cartridge. The housing of the cartridge, which forms the protective portion of the needle body, is designed in a similar manner to FIG. 1 and has notches (13 and 14) within each of which the locking lugs (12) of the cartridge can be attached. the second respective part of the body (2b) of the needle. The lancet system has a shaft (21) of the cartridge, which is arranged concentrically in the protective portion of the needle body and is used as a bearing for the lancet system in an auxiliary lancet penetration apparatus. The lancet system can be rotated around the shaft (21) in such a way that a needle, in each case, can be placed in relation to a drive unit (not shown) in the lancet penetration aid. Like the lancet system shown in Fig. 1, the lancet system of Fig. 2 also has tapered portions (5) within the protective portion of the needle body (2a) which are in the form of holes where the holes are also closed essentially hermetically by the second part of the body (2b) of the needle. Figure 2b shows a cross section through the lancet cartridge shown in Figure 2a. The system has a structure similar to that of Figure 1, but consists of a plurality of needles that are equipped with a second associated part of the body (2b) of the needle. Consequently, the lancet system shown in FIG. 2 has several parts that include an outer protective portion of the needle body and several second portions (2b) of the needle body. Figures 2c and 2d show the lancet system after use, in which all needles of the lancet system have already been used for lancet penetration. Of course it is also possible that only some of the needles have already been used in the lancet system. In this case the second part (2b) of the body of the needle would protrude only through some of the holes (5) of the protective portion of the body (2a) of the needle while the other holes would be hermetically closed by the body of the needle. the needle as shown in figure 2a. Depending on how the lancet system interacts, with the lancet penetration aid, ways are conceived where the reinsertion of the lancet system into an auxiliary lancet penetration device is blocked as soon as some of the needles have been used, or is blocked only after all needles have been used completely in the lancet system. Advantageously, it is also conceivable that the reinsertion of a partially used lancet system into the lancet penetration aid device is possible only when the system has been placed in relation to the actuator piston, in such a way that only unused lancets can be used. be used by the system. Figure 3 shows a rectangular needle body also comprising a plurality of needles in the form of a cartridge. The protective portion of the body (2a) of the needle also has holes (9) at its lower end (10) from which the needles can exit to carry out a lancet penetration operation. While it is in its rest position, ie when the lancet penetration operation is not carried out, the needle tips (not shown) are within the protective portion of the body (2a) of the needle in the that the needles can be guided in a mobile way. The body (2a) of the needle contains grooves in a lower portion (34) that surround the lower end (10) of the needle body, which makes it easier to hold it and therefore facilitates its manipulation by the user. The notches (33) are provided in this portion (34) as fasteners which, in an appropriately designed lancet-assisting apparatus, allow the lancet system to be secured in the lancet penetration aid during the insertion. The locking mechanism (31) is located in the center of the body (2a) of the needle as part of the body (2a) of the needle and can be guided in a mobile manner to an upper portion (35) of the body (2a) of the needle, and is first held in a starting position by means of arms (39) mounted on springs. There is also a notch (32) in the upper part (35) which secures the locking mechanism (31) when the locking mechanism (31) is guided along the upper part of the needle body (35). Figure 3b shows the lancet system after use. As illustrated in figure 3b, the locking mechanism (31) surrounding the body (2a) of the needle in the shape of a ring, is now placed on the upper end of the body of the needle, such that the locking mechanism (31) , in this position, widens the section (35) of the body of the needle. Once the locking mechanism (31) has been secured in its position, subsequently it is no longer possible to reinsert the lancet system due to the body of the enlarged needle.

Figures 3c and 3d illustrate in more detail the operation of the locking mechanism (31) which is used in the lancet system described above. In order to secure the locking mechanism (31) in the upper portion (35), the locking mechanism has locking arms (36) which engage in the notches (32). In the position shown in Figures 3b and 3c the locking arms (36) are mounted in springs against the lower edge of the notch (32) to secure the locking mechanism (31) against displacement. The retainer (37) also serves as an additional counterweight to the locking mechanism (31) against the projection (38) in the upper portion of the component (35) of the needle body. When the cartridge is inserted as shown in Figure 3e for the first use in a housing (70) of the lancing aid, the rear portion (35) of the cartridge housing is placed in an appropriately tapered position. (82) of the accommodation (70). In contrast, the front portion (80) of the housing (70) is enlarged, such that the enlarged diameter of the lancet system, due to the ring acting as the locking mechanism, can be placed accordingly in the housing of the apparatus. penetration aid with lancet. In this position the lancet system is maintained in the lancet penetration aid, in such a way that a drive unit (not shown) of the lancet penetration aid apparatus can be engaged in the cartridge housing in order to engage on a needle of the lancet system. The housing of the lancet penetration aid also has two detents (83, 84) which are adjacent to the locking mechanism (31) in this position of the lancet system in the lancet penetration aid. If the lancet system is removed from the housing of the lancet penetration aid, after use, the retainer (84) first has the effect that the locking mechanism (31) remains fixed in its position, in the housing, in the the lancet penetration aid, while the cartridge housing is pulled out of the area (82) of the lancet penetration aid. As a result the locking mechanism (31) is pushed along the body of the needle to the upper portion (35) of the needle body. In this process the locking mechanism (31) is secured with the needle body and the projection (38) and the retainer (37) blocks further movement of the locking mechanism along the body of the needle. If the locking mechanism (31) rests against the projection (38), an additional draft movement on the cartridge housing overcomes the resistance of the retainer (84) and the cartridge can be removed from the lancet penetration aid. The cartridge is now located outside the housing in a used condition as shown in Figure 3b where the locking mechanism (31) is permanently placed on the body of the needle due to the locking hooks (36) and the catch (37). If the lancet cartridge is reinserted into the housing of the lancet penetration aid, the cartridge can no longer be pushed into the tapered area (82) of the lancet penetration aid due to the enlarged circumference of the section. upper (35) of the body of the needle. Hence, it is no longer possible to place the lancet system in its original position in the lancet penetration aid. The lancet system can no longer be maintained in the lancet penetration aid. The coupling of individual needles to the driving unit of the lancet penetration aid, in order to carry out a lancet penetration operation, is blocked. Also, after the lancet system has been ejected, the user can easily recognize, in visual form, that the lancet system is a used system, due to the displaced ring. For this purpose it is also conceivable that the locking mechanism (31) has a protruding color. As an alternative to the change described in the body (2a) of the needle, it is also conceivable, for example, that the locking mechanism (31) can be moved through the notches (33) of the lancet system. In this case a reinsertion of the lancet system, in an auxiliary lancet penetration apparatus, would be prevented because the lancet system could no longer be secured in the lancet penetration aid. Other embodiments can be devised using a locking mechanism mounted in a movable manner, resulting in, for example, a reduction in the size of the upper section (35) of the needle body. In this case an unused lancet system, for example, in the state shown in Fig. 3b, is first placed in an auxiliary lancet penetration apparatus. A used lancet system would then be characterized in that the locking mechanism (31) would have been pushed above the portion (35) of the needle body, in such a way that the upper section (35) of the body (2a) of the needle would have a diminished size. Figure 3a would then represent the ejected state of the system. An appropriately designed lancet penetration apparatus would then have, for example, fasteners that could no longer interact with a lancet system that has been changed in this manner, and the reinsertion within the lancet system would not be and more possible. The locking elements of the locking mechanism and of the body (2a) of the needle would then have to be adapted accordingly. Furthermore, it is also conceivable that a mobile locking mechanism (31) ensures that the reinsertion of the lancet system is blocked and also protects the tips of the needles. In this case the tips of the needles would not be retracted, as shown in Figure 3, towards a protective portion of the needle body, after the lancet penetration operation. Hence, the tips of the needles would not be automatically protected in a resting position. For example, protection against the tips of the needles would not be ensured until the lancet system has been ejected from the lancet penetration aid. According to the locking mechanism shown in Figure 3a, a movement of the locking mechanism (31) elongates the body of the needle in the area of the needle tips, so that the tips of the needles are surrounded in a protective way by the blocking mechanism, and at the same time the locking mechanism is activated due to a change in the shape of the body. In this case a part of the body of the needle acts as a locking mechanism and also as a protective portion of the needle body, which surrounds the area of the needle tip, when the lancet system is ejected. The protective portion of the needle body and the locking mechanism then comprise a structural element of the needle body.

Figure 4 shows a rectangular lancet system in which several needles are placed in chambers (42) of the protective portion of the body (2a) of the needle. The upper section of the protective portion of the needle body has a locking mechanism (41) in the shape of a button that is located above the protective portion of the needle body and can move along a direction (45) towards the protective portion of the needle body. The upper part of the button has a guide groove (49) which engages a splice lip of the lancet penetration aid (not shown) in such a way that the lancet system can be placed securely in the auxiliary apparatus of the lancet. penetration with lancet. Once placed in this manner, an impeller plunger of the lancet penetration aid (not shown) can be coupled to the posterior area (48) of the needle (3) to perform a lancet penetration operation. For this purpose the needle moves along a direction (43) relative to the protective portion of the needle body and the tip of the needle leaves the protective portion (2a) of the needle body. As in the systems that have already been described, the needles are returned to the cartridge after the lancet penetration operation and the tip of the needle retracts into the body (2a) of the needle. The cartridge is moved to the next position by moving the actuator piston of the lancet unit along the direction (44) until the plunger can be engaged with a needle placed in the adjacent chamber (42) in order to carry out a new penetration operation with lancet. If the lancet system has to be replaced in the lancet-assisting apparatus, the plunger must first be moved out of the rear area (40) of the body (2a) of the needle. For this purpose the cartridge is moved to the next position and at the same time the button (41) is pressed by a ramp on the housing of the lancet penetration aid. The button (41) is now moved within the lancet system as shown in figures 4c and 4d, such that the section (50) of the button projects from the bottom of the body (2a) of the needle. In this position a notch (47) of the button (41) engages the back area (48) of the needle (3) which prevents the lancet-assisting auxiliary apparatus from engaging again with the lancet system, as shown in FIG. shows in the front view of figure 4d. Hence, a lancet penetration operation can not be carried out with a lancet system of Fig. 4c or 4d. In addition, the lancet system can not be reinserted into the lancet penetration aid due to the change in the shape of the needle body in the area (50). Hence, the lancet system can not be placed through the glider groove (49) as part of a fastening element.

Figure 5 shows a round-shaped lancet system which also contains several needles within the body of the needle. Similar to Figure 2, the lancet system has a multi-part needle body. A channel (52) is disposed along the axis of rotation of the lancet system and a plug (53) is located in this channel at the upper end of the lancet system. The plug (53) is held in its first position by expandable clamping arms (55) and this position represents the unused state of the lancet system. The clamping arms (56) engage in a taper of the plug (53) which is formed by planes (55) of the plug, which are inclined toward each other. When the lancet system is inserted into the lancing aid (70) the plug (53) is pressed into the channel (52) towards the needle tips, by means of a centering plunger (57) of the auxiliary penetration apparatus with lancet. The clamping arms (56) open when the plunger is depressed due to the inclined planes (55) of the plug (53). When the holding arms (56) of the lancet system are opened by the plunger (57) they can be coupled together. Hence, the plunger (57) can be inserted almost completely into the lancet system and is used as a bearing for the cartridge and for the positioning thereof. A drive unit designed appropriately, of the lancet penetration aid device, can be oriented in this way in relation to the lancets of the system, so that it can be coupled to a lancet and in such a way that a lancet penetration operation can be carried out. After the cartridge has been used, it is removed from the lancet penetration aid. For this purpose the plunger (57) is pulled out of the interior of the cartridge housing while the plug (53) remains at the lower end of the cartridge in the area of the needle tips. Consequently, a used lancet system is designed as shown in FIG. 5c in which the plug (53) is no longer contained in the upper section of the holding arms (56). If an attempt is made to insert the used lancet system into the lancet penetration aid, the plunger (57) collides with the upper portion (56) of the holding arms, which in their open state prevent the plunger from penetrating. in the lancet system. The absence of the stopper (53) prevents the plunger (57) of the lancet penetration aid apparatus from causing the opening of the holding arms and therefore the lancet system can not be placed in the lancet penetration aid. Figure 6 shows another embodiment of a lancet system that is placed inside an auxiliary lancet penetration apparatus. The figure 6a to 6d first show a lancet system which is similar to that of figure 1. Like figure 1 the system shown in figure 6 also has an elastomer (4) surrounding the needle tip in a sterile manner and a two-part needle body having a taper (5, 5 ') in its central part. The second part of the body (2b) of the needle whose movement is guided in the interior of the protective portion of the body (2a) of the needle also has arms (6) in its rear section, which can be coupled in an adjustment manner by the shape with a plunger (78) of the lancet penetration aid (72). As shown in Figure 6b and 6c, the plunger (78) engages a head (71) in the second part (2b) of the needle body and moves the needle along the axis (8) in the direction of penetration with a lancet. In this process the arms (6) of the body (2b) of the needle are pressed between them and the projections (11) are coupled behind the slits in the head (71). The mode of operation of the lancet penetration system is similar to that already described in FIG. 1 and therefore is only presented here again with respect to its interaction with the lancet penetration aid. The lancet penetration aid (72) has an immobilization lever (74) which is mounted to the lancet penetration aid and which performs a pivotal pivot movement on an axis (75). The locking lever (74) has a circular shape in a first area (77) in such a way that the locking lever can be engaged in an adjustment manner by the shape, in the taper (5) of the lancet system. Figure 6a shows the state of the lancet penetration aid apparatus, with the lancet system before use in the inserted state. If the lancet penetration aid is intended to be used, for a lancet penetration operation, the locking lever (74) is rotated approximately 90 ° either automatically, when a lancet penetration operation is triggered, or in user-separated form, such that the upper section (77) of the locking lever no longer engages in the taper (5, 5 '). The rotation of the locking lever is ensured by the fact that the auxiliary lancet penetration apparatus also has a depression (76) in the housing of the lancet penetration aid., which allows the locking lever to rotate about the axis of rotation (75). When the lancet penetration operation is carried out, the second part of the body (2b) of the needle can move along the protective portion of the body (2a) of the needle and a section of the body (2b) of the needle. needle exits through the hole in the body (2a) of the needle without being prevented by the locking lever (74). In this process, the tip of the needle is driven through the elastomer and the exit orifice (9) of the lancet system and through an exit orifice (73) of the lancet penetration aid. After the lancet penetration operation, the needle returns to its rest position during which, however, the second part of the needle body is secured in the notch (13) of the protective portion of the needle body. As already described in Figure 1, this results in a change in the outer shape of the needle body, in the area of the taper (5) since the second part of the body (2b) of the needle now protrudes from the hole of the body (2a) of the needle. After the lancet system has been removed from the lancing aid, the locking lever (74) rotates back to its initial position as shown in Fig. 6a. As indicated in FIG. 6d, a reinsertion of the lancet system into the lancet penetration aid is blocked by the immobilization lever (74). The locking lever (74) can no longer be engaged in the taper (5) of the used lancet system, since the taper (5) is partially closed by the second part of the body (2b) of the needle. Hence, the lancet system can no longer be placed and then maintained in its original position. The plunger (78) can no longer be engaged in the lancet system. It is prevented that the head (71) and the projections (11) form a connection by adjustment to the shape. Figures 6e to 6h show modalities similar to those of figures 6a to 6d in which the lancet system consists of a plurality of needles, such that they can be stored in a cartridge as shown in figure 2. The principles of operation are, as already described, identical and can be transferred from the system with a needle, to the system shown in figures 6e to 6h. At this point the intention is only to illustrate a modality that allows a cartridge to be reinserted, of which the needles have been used only partially. For this the user must rotate the cartridge relative to the housing of the lancet penetration aid, until the locking lever (74) can be engaged in a taper (5) that is not blocked by a body (2b) of the needle . This placement of the system. lancet in relation to the lancet penetration aid and consequently in relation to the drive piston, ensures that only one lancet that has not been used yet is used for the next lancet penetration operation. An advance of the lancet system is only in one direction of rotation, and a mechanism that allows only a rotation of the lancet system in 360 ° can be added, as required, in order to prevent lancet penetration aids, already used, be used again. Figure 7 shows another embodiment of a lancet system that occurs in the form of a round cartridge housing. The design of the needle body has several parts similar to those of the figures that have already been described. The sterile protection and the needles are also arranged as already described and therefore a more detailed description is omitted here. Similar to the system described in Figure 5, the locking mechanism shown in Figure 7 is also actuated when the lancet system is inserted into the lancet penetration aid. For this purpose the body (2a) of the needle has a locking mechanism (31) which has the shape of an outer ring surrounding the upper section (35) of the body of the needle. When placed in this position, the locking mechanism (31) essentially covers the elastic arms (90) which are located in the upper portion of the body of the needle (35). As a result the elastic arms (90) are pressed into the groove (95) of the body (2a) of the needle. The locking mechanism (31) also has a circular protrusion at its lower end, which enlarges the circumference of the body (2a) of the needle in this position. If the lancet system is inserted into an auxiliary lancet penetration apparatus, the circumference of the lancet assisting apparatus is selected such that the ring (96) can not be inserted into the lancet system. The ring is pressed down relative to the body of the needle, in the area of the tips of the lancets, when the lancet system is inserted into the auxiliary lancet penetration apparatus, by means of a lower edge (97) which acts as a counterpart for the housing of the lancet penetration aid. As a result, the spring-mounted locking arms (90) are released from the ring. The arms at rest are now in an open state in the lancet penetration aid and are pressed against the wall (98) of the inner housing of the lancet penetration aid. When a used lancet system is removed from the lancet assisting apparatus, the locking arms (90) slide along the inclined wall (98) of the housing in a tapered area of the housing of the auxiliary penetration apparatus. with lancet, and are first pressed into the groove (95) of the needle body, due to the inclined wall (98). Hence, the lancet system can be easily removed from the used area of the lancing aid. The lancet system used is subsequently present with a changed shape, as shown in Fig. 7c. When the system is reinserted into an auxiliary lancet penetration apparatus, the locking arms (90) are now open and therefore the circumference of the body (2a) of the needle is enlarged in the area (35) preventing thus an insertion of the lancet system into the narrow, frontal area of the lancet penetration aid. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects or products to which it refers.

Claims

CLAIMS Having described the invention as above, the contents of the following claims are claimed as property: 1. The lancet penetration aid to produce a hole in the skin, characterized in that it comprises: -a housing in which it can be inserted, at least partially, a lancet system, wherein the housing also has a fastening element that interacts with a corresponding fastening element of the lancet system, such that the lancet system is placed in the housing in a position defined, and - the housing comprises a hole from which a needle tip, of at least one needle, can exit from the lancet system, during a lancet penetration operation, and - a drive to drive at least one needle, in such a way that the needle is transferred from a resting position to a penetration position with a lancet and - l The needle is connected to a needle body, in such a way that one protective portion of the needle body, and the needle, can move relative to each other, and the protective portion of the needle body surrounds the less partially, the tip of the needle in a first position and the protective portion of the needle body, and the tip of the needle, are arranged, one relative to the other, in a second position, in such a way that the The tip of the needle is released from the protective portion of the needle body and the needle body also comprises a block mechanism which is actuated by an interaction with the lancet penetration aid and changes the body of the needle in the needle body. such that, after the expulsion of the lancet system, from the lancet penetration aid, it is prevented that the fastening element of the lancet penetration aid interacts with the fastening element of the lancet. ema of lancet when it is reinserted again. The auxiliary lancet penetration apparatus according to claim 1, characterized in that the holding element of the lancet-assisting auxiliary device is prevented from interacting with the holding element of the lancet system, in such a way that the system The lancet can not be reinserted into the lancet penetration aid. 3. The lancet penetration aid according to claim 1, characterized in that the lancet system and the auxiliary lancet penetration apparatus each have several fastening elements that act independently. 4. The lancet penetration aid according to claim 1, 2 or 3, characterized in that the locking mechanism prevents the interaction of the lancet system holding elements with the lancet penetration aid in a manner such that the lancet system can be held and placed in a position in the lancet penetration aid. 5. The lancet penetration aid according to claim 1, characterized in that the interaction of the fastening elements of the lancet penetration aid and the lancet system is prevented in such a way that the needle can not be driven by the driving mechanism. 6. The lancet penetration aid according to claim 1, characterized in that the locking mechanism separates the fastening elements spatially when the lancet system is reinserted into the lancet penetration aid. The lancet penetration aid according to claim 1, characterized in that the locking mechanism is activated when the lancet system is ejected from the lancet penetration aid. 8. The lancet penetration aid apparatus according to claim 1, characterized in that the locking mechanism is activated when the lancet system is inserted into the lancet penetration aid. 9. The lancet penetration aid according to claim 1, characterized in that the locking mechanism is actuated during a lancet penetration operation. The lancet penetration aid according to claim 1, characterized in that the protective portion of the needle body is transferred to its first position during the ejection of the lancet system. The lancet auxiliary penetration apparatus according to claim 1, characterized in that the first position of the protective portion of the needle body is the same as the rest position. 12. A lancet system for insertion into an auxiliary lancet penetration apparatus, characterized in that it comprises: - at least one needle with a tip for producing a hole in the skin and - a needle body with a fastening element that interacts with a fastening element of the lancet penetration aid, when the lancet system is inserted into the lancing aid, in such a way that the lancet system is placed in a defined position in the auxiliary penetration apparatus with lancet and - the body of the needle is connected with the needle in such a way that at least one protective portion of the body of the needle, and the needle, can be moved relative to one another, wherein: - the protective portion The needle body at least partially surrounds the tip of the needle in a first position and - in a second position, the protective portion of the needle body, and the tip of the needle, is n spatially separated one from the other, such that the tip of the needle is released by the protective portion of the needle body and the needle body also has a locking mechanism that can be actuated by interacting with the needle. an auxiliary lancet penetration apparatus and changes the body of the needle in such a manner that, after ejection of the lancet system, from the lancet penetration aid, the fastener element is prevented from interacting with a fastener of an auxiliary lancet penetration device when reinserted again. 13. The lancet penetration system according to claim 12, characterized in that the locking mechanism changes the shape of the body of the needle. The lancet penetration system according to claim 12, characterized in that the protective portion of the needle body is a cartridge housing containing a plurality of needles. 15. The lancet system according to claim 12, characterized in that the body of the needle comprises several parts. 16. The lancet system according to claim 12 or 15, characterized in that a part of the body of the needle comprises the locking mechanism that is actuated independently of the protective portion of the needle body. The lancet system according to claim 12, characterized in that the locking mechanism acts directly on the fastening element and covers or destroys the fastening element. 18. The lancet system according to claim 12, characterized in that the shape of the needle body is itself designed as a fastening element. 19. The lancet system according to claim 12, characterized in that the locking mechanism has a predetermined breaking point that breaks the body of the needle when it is ejected from the lancet system. 20. The lancet system according to claim 12, characterized in that the locking mechanism enlarges at least one area of the body of the needle. 21. The lancet system according to claim 12, characterized in that the locking mechanism reduces the size of at least one area of the needle body.